Diabetes Education App for Type 2 Diabetes

Overseen By Sally Snyder, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Reading Hospital and Medical Center

Disqualifiers: Pregnancy, Incarceration, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study. Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study. Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled. Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, participants in both study groups will continue their routine follow-up care with their primary care physicians, which suggests you may continue your current medications.

Is the Diabetes Education App for Type 2 Diabetes safe for humans?

The available research does not provide specific safety data for the Diabetes Education App for Type 2 Diabetes, but similar apps have been tested for usability and feasibility, showing they are generally well-received and promote positive health behaviors. ^{1 2 3 4 5}

How does the Diabetes Education App for Type 2 Diabetes differ from other treatments?

The Diabetes Education App for Type 2 Diabetes is unique because it provides an interactive and educational platform for self-management, using a mobile or web application to help users learn about and manage their condition effectively. Unlike traditional treatments that may focus solely on medication, this app emphasizes education and self-efficacy, offering tools like quizzes and a diabetes dictionary to enhance users' understanding and control of their diabetes. ^{1 5 6 7 8}

What data supports the effectiveness of the Diabetes Education App for Type 2 Diabetes treatment?

Research shows that using internet and technology-based tools for diabetes education can improve patient outcomes by providing personalized support and helping patients manage their condition more effectively. These tools allow patients to track their health data, receive timely feedback, and connect with healthcare providers and support networks, which can lead to better self-management and improved health outcomes. ^{9 10 11 12 13}

Who Is on the Research Team?

Luis A Murillo, MD, MPH

Principal Investigator

Reading Hospital Tower Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with uncontrolled Type 2 Diabetes (HA1c >8.0) who are patients at the Family Healthcare Center, Reading Hospital Tower Health. It's not for pregnant individuals, incarcerated people, those without a smartphone, or anyone unable to consent.

Inclusion Criteria

Current patients of the Family Healthcare Center, Reading Hospital Tower health.

I have Type 2 Diabetes with an HA1c level above 8.0.

Exclusion Criteria

I am able to give my own consent to participate in the study.

Identified special populations (pregnancy or individuals currently incarcerated)

Patients without access to their own smart phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm use the diabetes education app for 6 months, while control arm participants continue routine care

6 months

Routine follow-up appointments with primary care physicians

Follow-up

Participants are monitored for changes in HA1C, blood pressure, BMI, and self-efficacy for diabetes management

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes education web site application

Trial Overview The study tests a diabetes education app that provides videos on managing diabetes and lifestyle changes versus usual care without the app. The impact on blood sugar control (HA1C), body weight, blood pressure, and self-management confidence is measured.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Participants enrolled in the intervention arm will be given a 6-month access period to the diabetes education application designed by the study team. The web site will offer videos related to a specific areas of education concerning diabetes self-management. To encourage compliance, participant users will receive weekly notifications from the application that will guide them through viewing all videos in the series. Participants will continue routine follow-up appointments with their primary care physicians during the study period. There will be no restrictions on starting or stopping medications during the study period.

Group II: Control arm Active Control 1 Intervention

Participants in the control arm will not have access to the Diabetes Application. They will continue follow-up appointments according to the standard of care with their primary care physician, diabetic educators, etc. There are no restrictions on starting or stopping medications for patients within the control arm.

Who Is Running the Clinical Trial?

The Reading Hospital and Medical Center

Lead Sponsor

Trials

14

Recruited

1,500+

Reading Hospital Foundation

Collaborator

Trials

1

Recruited

120+

Complete Statistical Services (Consult-Stat)

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

A study evaluated 53 diabetes patient education websites out of 214 retrieved, revealing significant variability in the quality of information based on established educational criteria.

Improvements such as incorporating evidence-based medicine, emphasizing family support, and enhancing user feedback mechanisms could greatly enhance the effectiveness of these web-based resources for patient-centered diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the quality and contents of diabetes mellitus patient education on Internet. Thakurdesai, PA., Kole, PL., Pareek, RP.[2019]

The Web-based POEM system significantly improved diabetes management in 274 patients with type-2 diabetes, leading to better control of fasting blood glucose, HbA1c, and total cholesterol levels compared to a control group.

Patients using the POEM system logged in an average of 8.5 times per month, indicating high engagement, which contributed to their improved clinical outcomes over the study period from September 2003 to May 2004.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a patient-oriented education system for diabetes management. Lee, TI., Yeh, YT., Liu, CT., et al.[2022]

E-health educational interventions for patients with type 1 diabetes (T1D) did not show a significant difference in HbA1c levels compared to standard care, based on a meta-analysis of 6 randomized controlled trials involving 757 subjects.

The study emphasizes the need for more rigorous and well-designed trials to explore how e-health education can be effectively integrated into clinical practice for better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. Feigerlová, E., Oussalah, A., Zuily, S., et al.[2022]

Web-based interventions for managing type 2 diabetes, which include features like tracking blood glucose and scheduling physician visits, have been shown to improve patient engagement and health outcomes significantly.

Despite their effectiveness, comprehensive web-based diabetes management systems are not widely implemented due to high development costs and lack of reimbursement, which are barriers that need to be addressed for broader adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. Brown, LL., Lustria, ML., Rankins, J.[2022]

Information technology significantly enhances diabetes management by providing patients with tailored, just-in-time support, allowing for better self-management of their condition through online tools and resources.

The integration of technology in diabetes care enables clinicians to efficiently support a larger number of patients, facilitating continuous communication and personalized guidance without the constraints of traditional office hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet and information technology use in treatment of diabetes. Kaufman, N.[2022]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

A study evaluating diabetes self-management apps found that most do not adequately address the seven recommended self-management behaviors by the American Association of Diabetes Educators (AADE7™), with apps promoting only a median of two skills.

The reliability of app ratings based on descriptions and downloads was generally good, but the effectiveness of individual skills varied significantly, indicating a need for future app reviews to focus on performance testing and evidence-based design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to evidence-based guidelines among diabetes self-management apps. Breland, JY., Yeh, VM., Yu, J.[2021]

A pilot study involving 8 patients with poorly controlled type 2 diabetes showed that a mobile-based, gamified diabetes application is both usable and feasible, enhancing patient engagement and knowledge about diabetes management.

The application effectively motivated positive health behaviors and reinforced patients' confidence in managing their diabetes, indicating its potential as a valuable tool in diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Diabetes Application for Patients With Poorly Controlled Type 2 Diabetes Mellitus. Kho, SES., Lim, SG., Hoi, WH., et al.[2019]

Teachers who received diabetes training through a Web-based system scored significantly higher in knowledge (72.5% correct) compared to those trained with paper materials (66.4% correct).

The Web-based training was also rated significantly more satisfying (4.2 out of 5) than the traditional paper training (3.1 out of 5), suggesting that digital methods enhance both learning and satisfaction in diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based remote diabetes education for school personnel. Radjenovic, D., Wallace, FL.[2006]

The mobile application 'Diabetes & Nutrition' helped a 46-year-old man with newly diagnosed type 2 diabetes achieve significant improvements in weight (4.4 kg loss), waist circumference (5 cm reduction), and glycemic control (HbA1c decreased from 7.9% to 6.1%) over 3 months of self-management.

Despite initial success, the patient stopped using the app due to inconvenience, highlighting the need for future mobile applications to include features that encourage ongoing engagement and self-management in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month Outcomes of Mobile Phone Application-based Self-management in a Patient with Type 2 Diabetes. Hong, MK., Cho, YY., Rha, MY., et al.[2020]

The AIDA diabetes simulator, launched in 1996, has been widely accessed, with over 30,000 visitors and 10,000 downloads, demonstrating its popularity as a free educational tool for diabetes management.

Future versions of interactive diabetes education programs are expected to include advanced features like a 'virtual diabetic patient' for enhanced self-learning and teaching, emphasizing the importance of user-friendly interfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive educational diabetes simulators: future possibilities. Lehmann, ED.[2011]

A pilot program using a tailored iOS mobile app significantly improved diabetes knowledge and self-efficacy among rural adults with type 2 diabetes, indicating its potential as an effective self-management tool.

Participants found the app easy to use, suggesting that mobile technology can provide convenient access to important diabetes management resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Multimedia Tailored to Improve Diabetes Self-Management. Wood, FG., Alley, E., Baer, S., et al.[2015]

The AIDA diabetes simulator, which has been freely available online since 1996, has been accessed by over 74,000 users and downloaded more than 20,000 times, demonstrating its popularity as an educational tool for diabetes management.

The latest version, AIDA v4.3, includes improved modeling of glycosylated hemoglobin (HbA1c) levels and offers a 'virtual diabetic patient' feature for enhanced self-learning and teaching about diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The freeware AIDA interactive educational diabetes simulator--http://www.2aida.org--(2). Simulating glycosylated haemoglobin (HbA1c) levels in AIDA v4.3. Lehmann, ED.[2007]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of the quality and contents of diabetes mellitus patient education on Internet. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Development and evaluation of a patient-oriented education system for diabetes management. [2022]

3. England pubmed.ncbi.nlm.nih.gov

E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Internet and information technology use in treatment of diabetes. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Adherence to evidence-based guidelines among diabetes self-management apps. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Development of a Diabetes Application for Patients With Poorly Controlled Type 2 Diabetes Mellitus. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Computer-based remote diabetes education for school personnel. [2006]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Six-month Outcomes of Mobile Phone Application-based Self-management in a Patient with Type 2 Diabetes. [2020]

11. Italy pubmed.ncbi.nlm.nih.gov

Interactive educational diabetes simulators: future possibilities. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

Interactive Multimedia Tailored to Improve Diabetes Self-Management. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

The freeware AIDA interactive educational diabetes simulator--http://www.2aida.org--(2). Simulating glycosylated haemoglobin (HbA1c) levels in AIDA v4.3. [2007]